Brig Royd Osteoporosis Protocol (Updated December 2014) Osteoporosis is defined as systemic skeletal disorder, characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture DEXA definition - A ‘T-score’ of ≥ 2.5 standard deviations (SD) below the young adult mean has been classified as osteoporosis by the World Health Organisation (WHO). Overall fracture risk increases two-fold per unit SD decrease in BMD and this relationship is even greater for hip fractures and BMD measured at hip sites. In terms of T scores, a score of -2.5 or less confirms osteoporosis, between -1 and -2.4 confirms osteopaenia. Identifying patients at high risk of osteoporosis Clinical risk factors: Age Gender Low BMD Previous fragility # Parental history of hip # BMI < 19 Hormonal – premature menopause, prolonged amenorrhoea (not related to PCOS or pregnancy), use of depot provera > 5 years. Includes men post-orchidectomy/androgen deprivation/hypogonadism Drugs – oral steroids (any dose of oral corticosteroids for >3/12 OR 1 g Prednisolone or equiv. lifetime dose.) GnRH analogues, arimidex, anticonvulsant therapy, Glitazones, PPIs Lifestyle – smoking and alcohol intake (>3 units/day), immobility, Medical conditions – rheumatoid arthritis, IBD, Malabsorption, cystic fibrosis, hyperthyroidism, hyperparathyroidism, Cushing’s syndrome, vit D insufficiency, COPD, Type 1 DM, Chronic renal and hepatic disease. Consider using Qfracture - http://www.qfracture.org/index.php (or FRAX via systmone) Primary Prevention Women aged < 45 with recent premature menopause = HRT until 52 (unless contraindicated). Not for DEXA unless other risk factors Women aged > 50 and Men aged > 65 who have clinical risk factors: FRAX calculation o Low risk (<10%)– lifestyle advice, consider Qfracture repeat after 5 years unless risk factors change o Higher risk (>10%) – DEXA referral DEXA PIL http://www.patient.co.uk/health/dexa-scan Frail/>75 with clinical risk factors Falls assessment Check Vit D and calcium and consider further investigation if an underlying cause suspected. (e.g FBC, ESR, Electrolytes, Bone profile, TFTs, PTH, ALP, Coeliac screening) Treat without DEXA (as per 2° prevention) PMR Individuals > 65 or hx of prior fragility fracture - DEXA not required use bisphosphonate and calcium & vitamin D Individuals < 65 - Start calcium & vitamin D, DEXA scan and consider bisphophonate if T score less than -1.5 Secondary prevention (1) Women aged > 50 or men aged >65 with low trauma fracture DEXA referral Follow scan report recommendations (2) If abnormal DEXA but no history of # FBC, ESR, Electrolytes, Bone profile, TFTs, PTH, ALP, Coeliac screening, Oestrodiol (amenorrhoeic pre-menopausal), testosterone (men), Vit D Follow scan report recommendations. Treatments in order of preference: (from NOGG and NICE) (1) Alendronate (once weekly) (2) Risedronate (once weekly prep) – n.b ?often better tolerated and now off patent, but still second line as per NICE – (?likely to change with next guidance) (3) Consider ibandronate (once monthly) (4) Strontium (caution re VTE/CVD) – see link below; these patients should be reviewed every 6 months to reassess vascular risks (5) Raloxifene - not licensed for primary prevention, but is for secondary prevention in certain circumstances ( BNF osteoporosis treatment) All plus calcium/vit D – Calderdale formulary recommends generic coleclciferol 400unit/Calcium carbonate 1.5g chewable tablets BD (equivalent of adcal D3) If none of above tolerated – refer to rheumatology for advice. (?denosumab/teriparatide) PIL for patients on different treatments in osteoporosis (National Osteoporosis Society) Repeating DEXA - In line with PACE guidance (&BMJ) patients with osteoporosis should have a scan every 3 years and those with osteopaenia every 5 years. (please create patient alert with date of next DEXA and consider adding reminder to repeat prescriptions) Brig Royd Codes to use. (1) Referral for DEXA = /dexa (2) Fragility fracture = /fracture (3) T score = /dexat (4) Osteoporosis = /osteo QOF 2015/16; unchanged ( but remember to code DEXA results if osteoporotic as well as fragility fracture) OST001 OST002 OST003 The contractor establishes and maintains a register of patients: 1. Aged 50 or over who have not attained the age of 75 with a record of a fragility fracture on or after 1 April 2012 and a diagnosis of osteoporosis confirmed on DXA scan, and 2. Aged 75 years or over with a record of a fragility fracture on or after 1 April 2012 The percentage of patients aged 50 or over who have not attained the age of 75, with a fragility fracture on or after 1 April 2012, in whom osteoporosis is confirmed on DXA scan, who are currently treated with an appropriate bone-sparing agent. The percentage of patients aged 75 or over with a fragility fracture on or after 1 April 2012, who are currently treated with an appropriate bone-sparing agent. links for more info http://cks.nice.org.uk/osteoporosis-prevention-of-fragility-fractures#!scenario http://www.osteoporosis-resources.org.uk/ http://www.shef.ac.uk/NOGG/NOGG_Pocket_Guide_for_Healthcare_Professionals.pdf http://www.nos.org.uk/page.aspx?pid=264&srcid=234 DRUG HOLIDAYS The following guidance is taken from the National Osteoporosis Society and seems to be in line with current practice. Bisphosphonates have a long half-life in bones and their effects continue for some years after stopping. Due to concerns about atypical femoral fractures and osteonecrosis of the jaw a drug holiday should be considered after 5 yrs of treatment. Some patients may require long term treatment ( eg patients with multiple v ertebral fractures, treatment with high dose steroids, or patients with very low BMD at outset).The benefits are likely to outweigh the risks. NOGG guidance suggests a review of patients after 5 years treatment with alendronate or risedronate. This review should include the re-assessment of fracture risk in treated individuals using the FRAX tool, combined with a repeat DEXA as necessary, before deciding if continuing treatment is appropriate. Arrange DEXA after 5 yrs of treatment. If BMD same/improved/>2.5 withdraw treatment for 2-3 years then reassess with DEXA Fracture risk should be reassessed after any new fracture or every 2 years. Consider restarting treatment if fracture risk increases. If fracture risk is still above the intervention threshold; continue treatment for another 5 yrs. DENOSUMAB This is now under shared care scheme and GP responsibilities include Ensure compliance with vitamin D/ calcium Have recall system for 6 monthly injection Early treatment of skin infections/cellulitis which is an increased risk. Delay any invasive dental treatment until just before 6 monthly injection Refer back to specialist after 5 years.